Trials / Unknown
UnknownNCT02907762
Aorfix Intelliflex First in Human Study
Aorfix™ Generation IV Delivery System "IntelliFlex™" Study
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 10 (estimated)
- Sponsor
- Lombard Medical · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
The First In Human (FIH) study is a long-term, single center, non-randomized study established by Lombard Medical, Inc. to collect "on-label" data in the clinical setting on patients undergoing endovascular repair with IntelliFlex™, the latest generation of the Aorfix™ AAA Flexible Stent Graft Delivery System, for treatment of abdominal aortic and aorto-iliac aneurysms in anatomy where the aorta in the aneurysm neck is bent through an angle between 0° and 90°.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Endovascular aneurysm repair EVAR |
Timeline
- Start date
- 2015-11-01
- Primary completion
- 2021-11-01
- Completion
- 2021-11-01
- First posted
- 2016-09-20
- Last updated
- 2021-11-01
Source: ClinicalTrials.gov record NCT02907762. Inclusion in this directory is not an endorsement.